2010-15711. Change of Address; Abbreviated New Drug Applications; Technical Amendment

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA) is amending its regulations to update the address for applicants to submit abbreviated new drug applications (ANDAs) and ANDA amendments, supplements, and resubmissions. FDA is also updating the address for ANDA applicants to submit investigational new drug applications (INDs) for in vivo bioavailability and bioequivalence studies in humans that are intended to support ANDAs. This action is being taken to ensure accuracy and clarity in the agency's regulations.

DATES:

This rule is effective August 1, 2010.

FOR FURTHER INFORMATION CONTACT:

Martin Shimer, Center for Drug Evaluation and Research, Food and Drug Administration, 7500 Standish Pl., MPN II, Rockville, MD 20855, 240-276-8675.

SUPPLEMENTARY INFORMATION:

FDA is amending 21 CFR 314.440(a)(2) to update the address for applicants to submit ANDAs and ANDA amendments, supplements, and resubmissions. FDA is also amending 21 CFR 312.140(a)(1) to update the address for ANDA applicants to submit INDs for in vivo bioavailability and bioequivalence studies that are intended to support ANDAs. The new address for all these submissions is Office of Generic Drugs (HFD-600), Center for Drug Evaluation and Research, Food and Drug Administration, Metro Park North VII, 7620 Standish Pl., Rockville, MD 20855. This action is being taken to ensure accuracy and clarity in the agency's regulations.

Publication of this document constitutes final action on these changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has determined that notice and public comment are unnecessary because this amendment to the regulations provides only technical changes to update an address for the submission of ANDAs; ANDA amendments, supplements, and resubmissions; and INDs related to ANDAs.

List of Subjects

21 CFR Part 312

• Drugs
• Exports
• Imports
• Investigations
• Labeling
• Medical research
• Reporting and recordkeeping requirements
• Safety

21 CFR Part 314

• Administrative practice and procedure
• Confidential business information
• Drugs
• Reporting and recordkeeping requirements

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 312 and 314 are amended as follows:

PART 312—INVESTIGATIONAL NEW DRUG APPLICATION

1. The authority citation for 21 CFR part 312 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262.

§ 312.140

[Amended]

2. Section 312.140 is amended in paragraph (a)(1) by removing “II, 7500” and adding in its place “VII, 7620”.

PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

3. The authority citation for 21 CFR part 314 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 356a, 356b, 356c, 371, 374, 379e.

§ 314.440

[Amended]

4. Section 314.440 is amended in the first sentence of paragraph (a)(2) by removing “II, 7500 Standish Place., rm. 150” and adding in its place “VII, 7620 Standish Pl.”.

Dated: June 23, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.